Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium

Virginia Commonwealth University (VCU)

Status

Enrolling

Conditions

Delirium

Treatments

Device: Weighted Blanket

Study type

Interventional

Funder types

Other

Identifiers

NCT06161480

HM20027241

Details and patient eligibility

About

The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.

Full description

To examine the feasibility and acceptability of weighted blankets as a single component, nonpharmacologic strategy to prevent and/or mitigate delirium in an adult medicine critical care patient population. To examine the feasibility and acceptability of videoconferencing (VCU Health Zoom), EHR screening, and VCU and VCU Health infrastructure (REDCap, OnCore) for rural participant recruitment and research participation, remote HealthCare provider protocol training and research engagement, and remote research monitoring and support for rural patient population. To collect preliminary descriptive data and examine trends related to the use of weighted blankets to prevent and/or mitigate delirium to inform future efficacy trials in an adult medicine critical care patient population (e.g., Agitation, Delirium, ICU length of stay, number ventilator days, sedation/opioid medication usage).

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 years of age or older.
Requiring ICU level of care.
Have a primary medical diagnosis.
Proficient in English.

Exclusion criteria

BMI less than 18.5.
Significant deficit in cognitive functioning that is not expected to improve due to an end---stage disease stage or permanent injury (e.g., end-stage encephalopathy, traumatic or anoxic brain injury, dementia).
Known pregnancy.
Prisoners.
Presence of skin injury (e.g., surgical wound, pressure injury, moisture injury) in an anatomical location where additional weight/pressure of blanket could prevent healing and /or lead to an expansion of the injury.
Patients with skin injuries to areas easily left uncovered by the blanket (e.g., hands, feet) can be enrolled with additional communication to clinical team to leave areas uncovered to prevent additional injury.
Paralysis effecting an area the weighted blanket will cover.
Current neuromuscular blocking agent.
Presence of recent/unhealed fractures on an area the blanket will cover (e.g., lower limb long bone, rib, pelvis, spine).
History of claustrophobia reported by patient and/or their legally authorized representative (LAR).
Fever of 37.5°C (99.5°F).
Limited English proficiency.